The safety of COVID-19 vaccines in a large French series of patients with neuromuscular conditions and the impacts of vaccination on their daily lives

Abstract

This prospective observational study assessed how well patients with neuromuscular disorders (NMDs) tolerated coronavirus disease 2019 (COVID-19) vaccination, and the safety thereof. Patients treated in 55 expert centres of the French NMD (FILNEMUS) network were asked to complete online questionnaires that explored COVID-19 vaccine injection status, adverse effects (AEs), and the impacts thereof on the activities of daily living (ADLs). All patients were followed-up for 12 months. We enrolled 1,020 patients with various NMDs; 38% with myopathy, 33% peripheral neuropathy, 20% myasthenia and 5% spinal muscular atrophy (SMA). Of all patients, 18% were on immune system-modifying therapies. A total of 1,865 vaccine injections were given. Of all patients, 70.4% lacked AEs impacting ADLs (they experienced no AEs or minor AEs), 20.4% reported AEs compromising ADLs, 9% AEs preventing ADLs and 0.2% AEs that required hospitalisation. We found no association between AEs impacting ADLs and the NMD type, physiopathology, or treatment. However, correlations were found between the development of AEs that impacted ADLs and both the modified Rankin score at baseline and vaccination with mRNA-1273 (Moderna). The AE types and frequencies were similar to those of the general population. Our study is reassuring; COVID-19 vaccination is safe for patients with NMDs including those with immune system-mediated diseases and those who are receiving immune system-modifying therapies. Patients with severe disabilities were at an increased risk of AEs that impacted ADLs but this must be weighed against the fact that they are also at increased risk of severe COVID-19 infection. Our mRNA-1273 (Moderna) vaccine findings require confirmation; few patients received this vaccine compared to those injected with BNT162b2 (Pfizer-BioNTech).